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单纯使用 enamel matrix derivative 或联合使用双相磷酸钙骨移植治疗非包裹性骨下缺损:一项为期 12 个月的随机对照临床试验。

Treatment of Non-Contained Infrabony Defects With Enamel Matrix Derivative Alone or in Combination With Biphasic Calcium Phosphate Bone Graft: A 12-Month Randomized Controlled Clinical Trial.

机构信息

Department of Periodontology, University of Catalonia, Barcelona, Spain.

出版信息

J Periodontol. 2017 May;88(5):426-435. doi: 10.1902/jop.2016.160459. Epub 2016 Dec 13.

DOI:10.1902/jop.2016.160459
PMID:27958765
Abstract

BACKGROUND

Use of enamel matrix derivative (EMD) when dealing with non-contained defects may be limited because EMD does not maintain a space itself. Use of combined therapy has been proposed, using a bone graft in combination with EMD to avoid collapse of the flap into the bony defect during healing time. Therefore, the aim of this study is to evaluate the clinical and radiologic healing response of non-contained infrabony defects after treatment with a combination of EMD and biphasic calcium phosphate (BC) or EMD alone.

METHODS

Fifty-two patients with at least one infrabony defect ≥3 mm in depth with a probing depth (PD) ≥6 mm were randomly treated with EMD/BC or EMD alone. Clinical and radiographic parameters were evaluated at baseline, 6, and 12 months after surgery. To standardize the procedure, an acrylic stent and millimeter radiographic grid were used. The primary outcome was the change in clinical attachment level (CAL).

RESULTS

Analysis of the data demonstrated a statistically significant difference from baseline within each group (P <0.05), with a difference in clinical and radiographic parameters at 6 and 12 months. After 1 year, mean PD reductions of 3.14 ± 1.95 mm (39.6%) in the EMD/BC group and 3.30 ± 1.89 mm (48.7%) in the EMD group were achieved. A mean CAL gain of 2.38 ± 2.17 mm (24.9%) in the EMD/BC group and 2.65 ± 2.18 mm (36.2%) in the EMD group were obtained. Reduction in the infrabony component was 2.71 ± 1.79 mm (57.9%) in the test group and 2.60 ± 2.03 mm (28.5%) in the control group. There were no statistically significant differences between treatment groups.

CONCLUSIONS

It was concluded that treatment of non-contained infrabony defects with EMD, with or without BC, resulted in statistically significantly better results after 12 months compared with baseline measurements. In contrast, the combined approach did not result in a statistically significant improvement.

摘要

背景

在处理非局限性缺损时,使用釉基质衍生物(EMD)可能会受到限制,因为 EMD 本身不能维持空间。已经提出了联合治疗的方法,使用骨移植与 EMD 相结合,以避免在愈合过程中瓣塌陷到骨缺损中。因此,本研究的目的是评估使用 EMD 和双相磷酸钙(BC)联合治疗或单独使用 EMD 治疗非局限性骨下缺损的临床和放射学愈合反应。

方法

将 52 名至少有一个深度≥3mm、探诊深度(PD)≥6mm 的骨下缺损的患者随机分为 EMD/BC 组或 EMD 组。在基线、术后 6 个月和 12 个月时评估临床和放射学参数。为了标准化操作,使用了丙烯酸支架和毫米级放射网格。主要结果是临床附着水平(CAL)的变化。

结果

数据分析显示,每组内均与基线相比有统计学显著差异(P<0.05),6 个月和 12 个月时临床和放射学参数有差异。1 年后,EMD/BC 组 PD 减少 3.14±1.95mm(39.6%),EMD 组 PD 减少 3.30±1.89mm(48.7%)。EMD/BC 组 CAL 增加 2.38±2.17mm(24.9%),EMD 组 CAL 增加 2.65±2.18mm(36.2%)。骨下缺损的减少在试验组为 2.71±1.79mm(57.9%),在对照组为 2.60±2.03mm(28.5%)。两组之间无统计学显著差异。

结论

结论是,与基线测量相比,使用 EMD 单独或联合 BC 治疗非局限性骨下缺损,在 12 个月后可获得统计学上显著更好的结果。相比之下,联合治疗方法并未导致统计学上的显著改善。

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